Kornimate/medical-research-clean huggingface dataset:
evaluation of one silicone hydrogel contact lens and two hydrogel lenses in daily wear

Conditions: Myopia

Summary: to evaluate the comparative clinical performance of the fanfilcon a silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.

this 8-week, subject-masked, bilateral, two-part, cross-over evaluation will compare the clinical performance of fanfilcon a silicone hydrogel contact lens and competitive hydrogel contact lenses when worn daily. lenses will be replaced either on a 2-weekly or 4-weekly basis, depending on control lens group.

Eligibility criteria:
inclusion criteria: * be a currently adapted soft contact lens wearer (\>1 month of lens wear). * be at least 18 years of age. * refractive astigmatism \<1.00d in both eyes. * have clear corneas and be free of any anterior segment disorders. * be correctable through spherocylindrical refraction to 20/25 or better in each eye. * contact lens sphere requirement between -1.00d and -6.00d (inclusive). * require visual correction in both eyes (monovision allowed, no monofit). * have normal eyes with no evidence of abnormality or disease. for the purposes of this study a normal eye is defined as one having: 1. no amblyopia 2. no strabismus 3. no evidence of lid abnormality or infection 4. no conjunctival abnormality or infection that would contraindicate contact lens wear 5. no clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities) 6. no other active ocular disease. * own a mobile phone and be able to respond to sms survey during the period 8am-8pm. * willing to comply with the wear and study visit schedule. exclusion criteria: * using coopervision avaira vitality, j\&j acuvue 2 or coopervision biomedics 55. * require toric or multifocal contact lenses. * previously shown a sensitivity to any of the study solution components. * any systemic or ocular disease or allergies affecting ocular health. * using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance. * clinically significant (\>grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear. * any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea. * keratoconus or other corneal irregularity. * aphakia or amblyopia. * have undergone corneal refractive surgery or any anterior segment surgery. * abnormal lacrimal secretions. * has diabetes. * known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., hiv). * history of chronic eye disease (e.g. glaucoma). * pregnant or lactating or planning a pregnancy at the time of enrolment. * participation in any concurrent clinical trial or in last 30 days.
study of oxb-102 (axo-lenti-pd) in patients with bilateral, idiopathic parkinson's disease

Conditions: Parkinson Disease

Summary: this study consists of two parts. part a will evaluate the safety and tolerability of multiple doses of oxb-102 (axo-lenti-pd) in participants with parkinson's disease. part b will assess the safety and efficacy of the selected dose of oxb-102 in participants with parkinson's disease.

this study consists of two parts. part a is an open-label dose-escalation phase in which participants are enrolled in cohorts and will receive one of approximately three escalating doses of oxb-102 (axo-lenti-pd). part b is a randomized, double-blind phase in which participants will be randomized to either an active group receiving the selected dose from part a, or to a control group receiving an imitation surgical procedure (isp).

Eligibility criteria:
key inclusion criteria: 1. diagnosed with bilateral idiopathic pd 2. males/females between 30 and 70 years at the time of surgery 3. unified parkinson's disease rating scale (updrs) (part iii) score of between 30 and 60 in the "off" medication state 4. presence of motor fluctuations and/or dyskinetic movement 5. candidate for surgical intervention 6. hoehn and yahr (h\&y) stage 3 or 4 in the "off" medication state 7. stable dosing of pd medication, including l-dopa, for four weeks prior to screening with levodopa equivalent daily dose (ledd) of at least 900 mg key exclusion criteria: 1. history of psychosis or current treatment with dopamine blocking agents and prior regular exposure to antipsychotic agents 2. history of stereotactic or other surgery for the treatment of pd, including deep brain stimulation (dbs) 3. participation in a prior cell or gene transfer therapy study 4. contraindications to use of anaesthesia 5. current or anticipated treatment with anticoagulant therapy or the use of anticoagulation therapy that cannot be temporarily stopped around the time of surgery 6. diagnosis of multiple system atrophy 7. abnormal mri findings such as mega cisterna, septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumours, vascular diseases, trauma or arteriovenous malformations 8. presence of dementia

Keywords: parkinson's disease gene therapy oxb-102 axo-lenti-pd
evaluation of oxygen therapy delivery systems in hypoxemic acute respiratory failure

Conditions: Acute Respiratory Failure

Summary: the main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system optiflow® compared to 2 others standard oxygen therapy delivery systems (ospal®, non invasive ventilation).12 immunocompetent patients will compare the successive use of oxygen therapy delivery systems optiflow®/ospal® and 12 immunodeficient patients will compare the successive use of systems optiflow®/non invasive ventilation.


Eligibility criteria:
inclusion criteria: * patient hospitalized in the intensive care unit of nantes university hospital * signed informed consent * patient with not hypercapnic acute hypoxemic respiratory failure * immunocompetent and immunodeficient patient exclusion criteria: * age \< 18 years * pregnancy * contra-indication to non invasive ventilation * allergy to xylocaine * coagulation troubles * tracheotomized patient * urgent indication to intubation * hypercapnic acute respiratory failure * acute pulmonary edema * face or nose malformation

Keywords: acute respiratory failure oxygen therapy delivery systems non invasive ventilation high concentration mask hypoxemic pneumonia
effectiveness and safety of two forms of stavudine in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine (d4t). one form is taken once a day (extended release) and the other form is taken twice a day (immediate release).

patients are randomized to receive blinded stavudine extended release (d4t er) or immediate release (d4t ir) formulation. randomization is balanced by screening hiv viral load of less than 30,000 copies/ml or at least 30,000 copies/ml and by site. patients also receive open-label efavirenz (efv) and lamivudine (3tc). efficacy is evaluated over 48 weeks of the dosing period and safety is evaluated over the entire dosing period (56 weeks).

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are at least 18 years old. patients living in usa, puerto rico, australia, brazil, singapore, and thailand can be at least 12 years old (need consent of parent or guardian if under 18). * have a viral load of at least 2,000 copies/ml within 21 days of study entry. * have a cd4 count of at least 100 cells/mm3 within 21 days of study entry. * agree to use a barrier method of birth control (such as condoms) during the study. * are available for follow-up for at least 56 weeks. exclusion criteria patients will not be eligible for this study if they: * are pregnant or breast-feeding. * have taken nonnucleoside reverse transcriptase inhibitors (nnrtis) or protease inhibitors (pis) for more than 30 days and within 14 days of study entry. * have a new opportunistic (hiv-related) infection or condition requiring treatment. * have acute (early) hiv infection. * have diarrhea (at least 6 loose stools/day for at least 7 days in a row) within 30 days prior to study entry. * abuse alcohol or drugs. * have active hepatitis within 30 days prior to study entry. * have a history of peripheral neuropathy (a condition affecting the nervous system). * cannot take medications by mouth. * are allergic to certain antiviral drugs. * need to take certain medications that should not be taken with efv. * have certain other conditions or prior treatments that might affect the study.

Keywords: drug therapy, combination stavudine lamivudine rna, viral dosage forms reverse transcriptase inhibitors anti-hiv agents viral load efavirenz
efficacy and tolerability study in severe chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: efficacy and tolerability study in severe chronic obstructive pulmonary disease (copd) patients.

efficacy and tolerability study of symbicort turbuhaler (160/4.5µg/inhalation,2inhalations twice daily) added to atrovent (20µg/inhalation, 2 inhalations 4 times daily) + theophylline sr(0.1g/tablet, 1 tablet p.o. twice daily) compared with atrovent + theophylline sr in severe copd patients.

Eligibility criteria:
inclusion criteria: * signed and dated informed consent * men or women patients ≥ 40 years of age * diagnosis of copd with symptoms for more than 2 years and there is a history of at least one copd exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before visit 2 * forced expiratory volume in 1 second (fev1) ≤50% of predicted normal value, pre-bronchodilator and forced expiratory volume in 1 second (fev1) / forced vital capacity (fvc) \< 70%, pre-bronchodilator * total symptom score of 2 or more per day for at least half of run-in period (breathing, cough and sputum scores from the diary card) and complete morning recordings of digital peak flow meter data at least 7 out of the last 10 days of the run-in period exclusion criteria: * a history of asthma and seasonal allergic rhinitis before 40 years of age * patients who have experienced exacerbation of copd requiring hospitalisation and /or emergency room treatment and/or a course of oral steroids and/or intravenous corticosteroids and/or antibiotics within 4 weeks prior to visit 2 and/or during run-in period * patients with relevant cardiovascular disorder judged by the investigator * patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by the investigator * women who are pregnant, breast-feeding or of child-bearing potential judged by the investigator

Keywords: severe chronic obstructive pulmonary disease (copd) patients
non-interventional post marketing surveillance study to observe the safety and efficacy of vfend® iv

Conditions: Serious Fungal Infections

Summary: this is non-interventional study of voriconazole iv formulation in clinical use, which was mandated by the korean government agency following the approval of vfend in the republic of korea.


Eligibility criteria:
inclusion criteria: * invasive aspergillosis and other serious fungal infections. exclusion criteria: * n/a

Keywords: voriconazole korea invasive fungal infection
maxart: early access to art for all in swaziland

Conditions: HIV/AIDS

Summary: the purpose of this study is to evaluate the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all hiv-positive individuals in swaziland's government-managed health system.

the clinical evidence in support of offering antiretroviral treatment (art) for all hiv-positive individuals to improve patient health outcomes and reduce hiv incidence is building, and the resource-limited countries where this approach could have the biggest impact want to evaluate if this is a feasible and effective intervention to turn the course of their hiv epidemics. the maxart early access to art for all (eaaa) implementation study was designed to determine the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all hiv-positive individuals in swaziland's government-managed health system. this is a 3-year randomized stepped wedge design with open enrollment for all adults 18 years and older across 14 rural health facilities in swaziland's hhohho region. primary endpoints are retention and viral suppression. secondary endpoints include art initiation, adherence, drug resistance, tuberculosis, hiv disease progression, and cost per patient per year. sites are grouped to transition two at a time from the control (standard of care) to intervention (eaaa) stage at each 4-month step. this balanced design will result in approximately one half of the observations being under an intervention clinic, and the other half under control. power calculations were conservatively based on the estimated number of individuals expected to enroll in the study comparing the first 12-month measure of retention and 6-month of viral suppression on art of those entering clinics during their control stage versus those that will be entering a clinic during intervention period. a strategic mix of multidisciplinary research methodologies will be applied to meet the study aim, including implementation science, social science research, economic evaluations, and hiv incidence modeling.

Eligibility criteria:
inclusion criteria: * all art-naive hiv-positive individuals who are 18 years of age or older - excluding pregnant or breastfeeding women - who attend the health facilities included in the study will be asked for their consent to enroll in the study. exclusion criteria: * all hiv-positive individuals who \< 18 years of age or older and pregnant or breastfeeding women. * all hiv-positive individuals who did not consent to participate or who have already been initiated on art.

Keywords: hiv/aids, swaziland
the role of matrix metalloproteinases (mmps) in orthodontic tooth movement

Conditions: Tooth, Impacted; Molar, Third

Summary: the purpose of this study is to test whether the two mmps can be up-regulated during orthodontic treatment. alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different periods of time in volunteers.

long treatment time is a major factor causing high fees for orthodontic treatment. patients would have dental caries or periodontitis resulting from improper oral hygiene care during this long treatment period. how to speed up the tooth movement which determines the duration of orthodontic treatment, can help more people to obtain good occlusion and esthetics. orthodontic force on a tooth induces bone resorption on the compression side and bone deposition on the tension side, thus the bone remodels and then the tooth moves. therefore, bone resorption is the rate-limiting step of a lengthy orthodontic treatment. bone resorption is a complex process. the mineral component is dissolved by acid from osteoclasts. on the other hand, the organic components are digested with proteolytic enzymes secreted from osteoblasts and osteoclasts. we focus on our study on specific proteases which can digest extracellular matrix, called matrix metalloproteinases (mmps). osteoblast-derived mmps play an important role during initiation of bone resorption. however, the mechanism of its regulation is not clear. the past studies applied stretching or tension on single layer of cultured cells to characterize cellular response to the mechanical stimulation. now we simulate part of the bone resorption process by cultivating osteocyte-like cells in three-dimensional collagen gel under periodical compression. in a preliminary study, we focus on transcriptional changes of mmps upon compression in an osteosarcoma cell line mg-63. initial data form microarray indicated specific increase of two mmps expression after one day of compression. this increased expression was specific because the levels of house-keeping genes (ex. beta-actin or gapdh) and bone-specific markers were unaltered. therefore, we proposed that increased mmp expression of osteoblasts under compression is the first step for bone remodeling switching from synthesis to degradation of osteoid. in order to test this hypothesis, the following specific aims will be achieved: 1. to test whether these two mmps can be up-regulated during orthodontic treatment. alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different periods of time in volunteers. in situ hybridization and immunohistochemistry analysis for mmps will reveal their roles in this physiological process. 2. to optimize the regulation by changing the magnitude and frequency of the pressure, and characterize the time table for these changes.

Eligibility criteria:
inclusion criteria: * two mandibular third molars containing at least one mesially angular impaction with crown exposed to oral cavity exclusion criteria: * pregnancy

Keywords: orthodontic tooth movement matrix metalloproteinase orthodontics
transversus abdominis plane block for post-operative analgesia following cesarean section

Conditions: Analgesia

Summary: postpartum analgesia is a common concern after cesarean section (cs). the quality of postoperative recovery is improved by opioid sparing pain control approaches. the transversus abdominis plane block (tapb) is an effective technique for postpartum analgesia after cesarean section. pregnancy results in thinning of the internal oblique aponeurosis; with increased incidence of missing the second pop to reach the transversus abdominis plane (tap). the classic blind approach to the tap is associated with several complications; so, it has been largely replaced by the ultrasound-guided approach to the tap. the ultrasound-guided approach to the tapb was first described by hebbart and his colleagues in 2007.ultrasound-guided tapb improves the success of the block, reduces the volume of local anesthetic used and prevents the potential injury of adjacent structures. surgical approach to the tapb was also described, it is a quick and easy approach of establishing a reliable block. the surgeon performs an intra-abdominal approach to the tapb; by which asepsis is easily attained, visible and tactile confirmation of correct needle placement may be achieved with no risk of damage to the viscera but care must be given to avoid injury of the inferior epigastric vessels.

compare the transversus abdominis plane block via the modified surgeon assisted approach (study group), to the ultra-sound guided approach (control group); as regards the post-operative analgesia following cesarean section.

Eligibility criteria:
inclusion criteria: * asa physical status i and ∏ * primigravidas * aged 21-40 years * bmi ˂ 40 * body weight ˃ 60 kg * singleton pregnancy * gestational age of ≥37 weeks * undergoing elective caesarean section under spinal anesthesia. exclusion criteria: * parturient refusal * parturient with a bmi \> 40 * body weight \< 60 kg * asa physical status ≥ iii * known local anesthetic (la) allergy •contraindications to spinal anesthesia * parturients who received analgesics in the past 24 hours * infection at the site of the block.

Keywords: post-operative analgesia transversus abdominis plane block
a study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (cidp, an autoimmune disorder that affects the peripheral nerves)

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Summary: this is the open-label extension study of phase ii argx-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with cidp. patients already stabilized on efgartigimod ph20 sc will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod ph20 sc.


Eligibility criteria:
inclusion criteria: 1. ability to understand the requirements of the trial, provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits) of this trial. 2. male or female patient with one of the following options: * have completed the week-48 visit of stage b of the argx-113-1802 trial and are considered to be eligible for treatment with efgartigimod ph20 sc; or * have deteriorated during stage b of the argx-113-1802 trial and are considered to be eligible for treatment with efgartigimod ph20 sc, or * have been offered the participation in the ole trial due to early termination of the argx-113-1802 trial (because sufficient events for the primary endpoint analysis of the that trial have been reached and it is stopped) and are considered to be eligible for treatment with efgartigimod ph20 sc treatment; or * have completed the week-48 visit of the previous cycle of the ole trial and are considered to be eligible to continue with efgartigimod ph20 sc treatment. 3. women of childbearing potential who have a negative urine pregnancy test at baseline before imp administration. 4. women of childbearing potential must use an acceptable method of contraception from signing the icf until the date of the last administration of imp. exclusion criteria: 1. week-48/ed visit in the argx-113-1802 trial or the week-48 visit of the previous ole participation occurred more than 14 days prior to sd1 of the ole trial or the start of a new treatment cycle in the ole trial and more than 21 days since the last dose of imp. 2. pregnant and lactating women and those intending to become pregnant during the trial. 3. patients with clinical evidence of other significant serious disease or patients who underwent a recent or have a planned major surgery, or patients who (intend to) use prohibited medications (see protocol) and therapies during the trial, or any other reason which could confound the results of the trial or put the patient at undue risk.
eluvia des for the patients with femoropopliteal artery lesions.

Conditions: Vascular Diseases; Stent Complication

Summary: this study is a multicenter, prospective, observational study, aiming to enroll 400 patients with peripheral arterial disease in the femoral-popliteal segment implanted with eluvia stent. each patient was followed up for 2 years. the technical success rate, target lesion patency rate, quality of life improvement, cost of eluvia stent implantation, and other outcomes will be analysed.


Eligibility criteria:
inclusion criteria: 1. rutherford stage 2-5. 2. at least 90% stenosis or occlusion of the femoropopliteal artery. 3. eluvia stents are used for target lesions. 4. agree and sign the informed consent form exclusion criteria: 1. life expectancy is less than 1 year. 2. those with severe infection and gangrene of the limbs or those with tissue defects beyond the plane of the toes (ie major tissue loss), who may undergo major amputation even if the blood vessels are opened. 3. patients and their families are reluctant to join the observational study, or have difficulty in communication and are unable to assess the quality of life. 4. patients with in-stent restenosis of the femoral popliteal artery. 5. patients with acute arterial thrombosis.